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Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229189
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : March 8, 2012
John Snow, Inc.
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Brief Summary:

Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency

The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.

Condition or disease Intervention/treatment
Vitamin D Deficiency Pre Eclampsia Stillbirths Low Birth Weight Prematurity Dietary Supplement: Vitamin D Dietary Supplement: Placebo

Detailed Description:

The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population.

The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
Study Start Date : February 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Maternal and Neonatal Intervention Arm
Pregnant women will be individually randomized; a daily dose of vitamin D in 4000 IU will be given to Intervention group, started at 20-22 weeks of pregnancy till the time of delivery. The infants of this group will further stratify into two groups, one group will receive 400 IU of Vitamin D for 6 months as Intervention.
Dietary Supplement: Vitamin D
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
Placebo Comparator: Maternal and Neonatal Control Arm Dietary Supplement: Placebo
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.

Primary Outcome Measures :
  1. Maternal and Neonatal complications [ Time Frame: six months post enrolement ]
    Preeclampsia, hypertension ,poor weight gain etc during pregnancy.Still birth rates, Rate of low birth weight, prematurity,Neonatal seizures, Infants with growth failure, signs and symptoms of vitamin D deficiency. Infants with infections: pneumonia, diarrhea and Receptor polymorphism

Secondary Outcome Measures :
  1. Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency [ Time Frame: Six months post recruitment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.

Exclusion Criteria:

  • Pregnant women with pre existing type 1 or type II diabetes
  • Women with multiple fetuses, babies (twins, triplets)
  • Pregnant women with high level of Vitamin D
  • Babies with multiple congenital anomalies
  • Babies with serious birth injury, birth asphyxia and serious infections
  • Low birth weight less than 1.5
  • Refuse to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229189

Project Office Aga Khan University
Pind Dadan Khan, Punjab, Pakistan, 49040
Sponsors and Collaborators
Aga Khan University
John Snow, Inc.
Principal Investigator: Zulfiqar A Bhutta, FRCPCH, PhD Aga Khan University

Additional Information:
Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University Identifier: NCT01229189     History of Changes
Other Study ID Numbers: Vitamin D Study
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
Vitamin D
Pregnant women and their neonates

Additional relevant MeSH terms:
Birth Weight
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Deficiency Diseases
Nutrition Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Death
Pathologic Processes
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents